[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1004.3]

[Page 611]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1004_REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC 
PRODUCTS--Table of Contents
 
Sec. 1004.3  Plans for the replacement of electronic products.

    Every plan for replacing an electronic product with a like or 
equivalent product shall be submitted to the Secretary in writing, and 
in addition to other relevant information which the Secretary may 
require, shall include:
    (a) Identification of the product to be replaced.
    (b) A description of the replacement product in sufficient detail to 
support the manufacturer's contention that the replacement product is 
like or equivalent to the product being replaced.
    (c) The approximate number of defective product units which have 
left the place of manufacture.
    (d) The manner in which the replacement operation will be effected 
including the procedure for obtaining possession of the product to be 
replaced.
    (e) A time limit, reasonable, in light of the circumstances for 
completion of the replacement.
    (f) The steps which the manufacturer will take to insure that the 
defective product will not be reintroduced into commerce, until it 
complies with each applicable Federal standard and has no defect 
relating to the safety of its use.
    (g) The system by which the manufacturer will provide reimbursement 
for any expenses for transportation of such product incurred in 
connection with effecting the replacement.
    (h) The text of the statement which the manufacturer will send to 
the persons specified in Sec. 1003.10(b) of this chapter informing such 
persons;
    (1) That the manufacturer, at its expense, will replace the 
electronic product involved,
    (2) Of the method by which the manufacturer will obtain possession 
of the product and effect the replacement,
    (3) That the manufacturer will reimburse such persons for any 
transportation expenses incurred in connection with effecting such 
replacement, and
    (4) Of the manner in which such reimbursement will be made.
    (i) An assurance that the manufacturer will provide the Secretary 
with progress reports on the effectiveness of the plan, including the 
number of electronic products replaced.